Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Macroscopic evidence of damage to the cervical, vulvar, or vaginal epithelium, including ulceration and other lesions, severe erythema, or severe edema, related or not related to the study gel or applicator

Secondary Outcome Measures:

Adherence to the study gel regimen

acceptability of the study gel

Enrollment:

200

Study Completion Date:

October 2007

Detailed Description:

While the male condom is effective in preventing sexual transmission of HIV, its use is hampered by deeply rooted cultural and social barriers. About half of all HIV infections worldwide occur in women, yet the only available female-controlled method of HIV prevention is the female condom. Alternative prevention tools, such as vaginal microbicides, are urgently needed to slow the rapid spread of heterosexual HIV infection.

This study will last 24 weeks, with an additional 10 weeks of follow-up for participants with chronic hepatitis B virus (HBV) infection. Participants will be randomly assigned to one of four arms. Arm A participants will insert a vaginal tenofovir 1% gel two hours prior to vaginal intercourse for a maximum of two daily applications. Arm B participants will insert a vaginal placebo gel two hours prior to vaginal intercourse for a maximum of two daily applications. Arm C participants will insert a vaginal tenofovir 1% gel once daily at bedtime or during the longest period of daily rest. Arm D participants will insert a vaginal placebo gel once daily at bedtime or during the longest period of daily rest.

A medical and menstrual history update, pregnancy test, HIV and sexually transmitted infections (STI) risk reduction counseling, and interview to assess behaviors toward vaginal gel use will occur during all study visits. HIV/STI counseling and testing, urinalysis, and blood collection will occur at study entry and at Week 24. Pelvic exam with colposcopy and vaginal swab collection will occur at study entry and Weeks 4, 12, and 24. For participants with chronic HBV, additional blood will be collected to monitor hepatitis B infection at study entry and Weeks 12, 24, 28, 32, and 36.

Eligibility

Ages Eligible for Study:

18 Years to 50 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

HIV uninfected

Good general health

Sexually active

Willing to use acceptable methods of contraception, including male latex condoms for all acts of intercourse

Willing to undergo all study-related assessments and adhere to the requirements of the study

Exclusion Criteria:

Menopausal or postmenopausal

Hysterectomy

Abnormal screening results for several gynecologic exams

Taking or planning to take tenofovir, adefovir, or any other medication for chronic HBV infection

History of latex allergy

History of adverse reaction to tenofovir or adefovir

Use of a diaphragm or spermicide for contraception

Prior participation in the study

Prior participation in any vaginal microbicide, spermicide, or other drug study within 30 days of study entry

Gynecologic surgical procedure within 90 days of study entry

Illicit injection drug use within 12 months of study entry

History of vaginal intercourse more than an average of two times per day in the two weeks prior to study screening

Any other criteria that, in the investigator's opinion, may interfere with the study

Current pregnancy or previous pregnancy within 90 days of study entry

Breastfeeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111943